MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-13 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[90303945]
The customer contacted the siemens customer care center (ccc) to report the discordant carbon dioxide concentrated (co2_c) result. A siemens technical applications specialist (tas) was dispatched to the customer site. The tas reviewed the patient data and explained to the customer that since sodium was 141 mmol/l and chloride was 104 mmol/l, any co2_c result greater than 37 would calculate a negative anion gap and should have been questioned. The customer understood this observation and will reinforce this with their staff. The tas specialist verified that the software set up and contamination settings were up to date. The tas performed precision testing and reviewed the patient data and the event log and observed that an emergency stop had occurred. The customer had not performed shutdown wash. The tas explained to the customer that if an emergency stop is pressed a shutdown wash must be performed in order to verify that the system is completely clean and operational prior to running any samples. The tas performed a precision run for co2_c, which was acceptable. The tas checked all the fluidics to make sure that there were no overflows and correct cleaning was occurring. The cause of the discordant carbon dioxide concentrated (co2_c) result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[90303946]
A discordant, falsely high carbon dioxide concentrated (co2_c ) result was obtained on one patient sample on an advia chemistry xpt instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on an alternate instrument, resulting lower. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant carbon dioxide concentrated (co2_c ) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00555 |
| MDR Report Key | 6949793 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-09-15 |
| Date Added to Maude | 2017-10-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | ADVIA CHEMISTRY XPT |
| Product Code | CHS |
| Date Received | 2017-10-13 |
| Model Number | ADVIA CHEMISTRY XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | ADVIA CHEMISTRY XPT |
| Product Code | JJE |
| Date Received | 2017-10-13 |
| Model Number | ADVIA CHEMISTRY XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-13 |